Antibiotic Selection PressureASARI IINCT03140826
Amplification and Selection of Antimicrobial Resistance in the Intestine II
An observational study of Antibiotic Selection Pressure, run by University Hospital Tuebingen at 2 sites in Germany.
Trial summary
Stool samples will be collected from two groups of neutropenic patients in the case that a therapy with either meropenem or piperacillin/tazobactam is needed due to a suspected infection. The intestinal resistome will be determined and quantified using shotgun metagenomics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Selection Pressure
- What is being tested?
- meropenem
- How many people
- 60 participants
- Where
- 2 sitesGermany
- Study dates
- 30 Jan 2018to 31 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hemato-oncological disease in neutropenia or with expected neutropenia
Who may be able to join
- Patients with hemato-oncological disease in neutropenia or with expected neutropenia
- Need for treatment with meropenem or piperacillin-tazobactam
Who cannot join
- pregnancy
- HIV, HBV, HCV
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Hospital Cologne
Cologne, 50935
Institute of Medical Microbiology and Hygiene, University Hospital of Tuebingen
Tübingen, 72076
About this study
Stool samples will be collected from two groups of neutropenic patients in the case that a therapy with either meropenem or piperacillin/tazobactam is needed due to a suspected infection. The intestinal resistome will be determined and quantified using shotgun metagenomics. Based on this, regression models will be used to determine the actual selection pressure caused by these drugs, and both selective forces will be compared. The results will reveal if there is a drug that causes a lower selection pressure compared to the other. The study aims to generate knowledge that is required to design effective antibiotic stewardship programs.
- Conditions
- Antibiotic Selection Pressure
- Being tested
- meropenem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
meropenemDrug
Also called piperacillin-tazobactam
Antibiotics to treat infections.
| Study group | Role | What they receive |
|---|---|---|
| Meropenem arm | Patients receiving meropenem to treat an infection. Receives: Drug: meropenem | |
| Pip-Tazo arm | Patients receiving piperacillin-meropenem to treat an infection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic Selection Pressure
Degree of the change of the intestinal resistome.
Measured: under treatment, max. 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start30 Jan 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic Selection PressureStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Cologne
- Responsible party
- Principal investigator, Dr. Matthias Willmann, University Hospital Tuebingen
- Investigators
- Matthias Willmann, Prof. Dr., Principal investigator, University Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140826
- Sponsor's protocol ID
- ASARI-II
- Acronym
- ASARI II
- Status last verified
- Jul 2020
- First submitted
- 2 May 2017
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplification and Selection of Antimicrobial Resistance in the Intestine II
- ClinicalTrials.gov ID
- NCT03140826
- Acronym / sponsor ID
- ASARI II / ASARI-II
- Conditions
- Antibiotic Selection Pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- University Hospital of Cologne
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stool samples will be collected from two groups of neutropenic patients in the case that a therapy with either meropenem or piperacillin/tazobactam is needed due to a suspected infection. The intestinal resistome will be determined and quantified using shotgun metagenomics. Based on this, regression models will be used to determine the actual selection pressure caused by these drugs, and both selective forces will be compared. The results will reveal if there is a drug that causes a lower selection pressure compared to the other. The study aims to generate knowledge that is required to design effective antibiotic stewardship programs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meropenem arm | – | Drug: meropenemPatients receiving meropenem to treat an infection. |
| Pip-Tazo arm | – | –Patients receiving piperacillin-meropenem to treat an infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hemato-oncological disease in neutropenia or with expected neutropenia
Key inclusion criteria (2 listed)
- Patients with hemato-oncological disease in neutropenia or with expected neutropenia
- Need for treatment with meropenem or piperacillin-tazobactam
Key exclusion criteria (2 listed)
- pregnancy
- HIV, HBV, HCV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| meropenemAlso: piperacillin-tazobactamAntibiotics to treat infections. | Drug | Meropenem arm |
Primary outcome
Antibiotic Selection Pressure
Time frame: under treatment, max. 10 days
Degree of the change of the intestinal resistome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Willmann, Prof. Dr. principal investigator
University Tuebingen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Selection Pressure, run by University Hospital Tuebingen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic Selection Pressure (time frame: under treatment, max. 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.